Chronic hepatitis C
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with chronic hepatitis C who treat with Ledipasvir/Sofosbuvir combination therapy.
Exclusion criteria
Exclusion criteria: 1.History of allergy to Ledipasvir and Sofosbuvir. 2.Decompensated liver cirrhosis 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Patient with dialysis or patients with severe renal function disorder (eGFR<30ml/min/1.73m2) 8.Receiving contraindicated drugs for Ledipasvir and Sofosbuvir combined therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3.Change of renal function during a treatment period 4. Frequency of a side effect during a treatment period 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration. | — |
Countries
Japan
Contacts
Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology